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cladribine

Last Updated: June 20, 2018
Result type: Reports
Project Number: SR0546-000
Product Line: Common Drug Review

Generic Name: cladribine

Brand Name: Mavenclad

Manufacturer: EMD Serono, a Division of EMD Inc., Canada

Indications: Multiple Sclerosis, relapsing

Submission Type: New

Project Status: Active

Biosimilar: No

Fee Schedule: Schedule A

Key Milestones2

Call for patient input postedNovember 03, 2017
Patient group input closedDecember 22, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsJanuary 09, 2018
Patient group comments on input summary closedJanuary 16, 2018
Clarification:

- Patient input summary feedback received

Submission receivedDecember 01, 2017
Submission accepted for reviewDecember 15, 2017
Review initiatedDecember 18, 2017
Draft CDR review report(s) sent to applicantMarch 28, 2018
Comments from applicant on draft CDR review report(s) receivedApril 09, 2018
Redaction requests from applicant on draft CDR review report(s) receivedApril 16, 2018
Clarification:

- Manufacturer waived the opportunity to request redactions

CDR review team's comments on draft CDR review report(s) sent to applicantMay 04, 2018
Canadian Drug Expert Committee (CDEC) meetingMay 16, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansMay 30, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedJuly 12, 2018
Clarification:

- Request for extension to embargo period received from the manufacturer

- Embargo extension request under review by CADTH

- Embargo extension request granted

Tags

multiple sclerosis, nervous system, multiple sclerosis, relapsing-remitting, cladribine; RRMS